SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): August 8, 2019
(Exact Name of Registrant as Specified in Charter)
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|280 East Grand Avenue, South San Francisco, California 94080|
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(Former name or former address, if changed since last report)
|Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:|
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [ ]
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Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, $0.001 par value||CYTK||The Nasdaq Global Select Market|
Item 2.02. Results of Operations and Financial Condition.
On August 8, 2019, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: August 8, 2019||By:||/s/ Robert Wong|
|VP, Chief Accounting Officer|
Cytokinetics Reports Second Quarter 2019 Financial Results
Completed Enrollment in GALACTIC-HF with More than 8,200 Heart Failure Patients
Results from Phase 1 Study of CK-274 to be Presented at HFSA in September 2019; Phase 2 Clinical Trial Expected to Begin in Q4
SOUTH SAN FRANCISCO, Calif., Aug. 08, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the second quarter of 2019. Net loss for the second quarter was $32.1 million, or $0.56 per share, compared to net loss for the second quarter of 2018 of $27.5 million, or $0.51 per share. Cash, cash equivalents and investments totaled $175.1 million at June 30, 2019.
“During the second quarter, we made progress across the breadth of our pipeline, with particular emphasis on our investigational medicines for cardiovascular diseases of muscle dysfunction,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Our recently completing enrollment in GALACTIC-HF represents a significant milestone towards potentially bringing forward a novel therapy to address the high mortality and hospitalization rates in patients with heart failure. Additionally, we are pleased with encouraging data arising from the Phase 1 study of CK-274 and look forward to the planned initiation of a Phase 2 trial in patients with obstructive hypertrophic cardiomyopathy later this year. Our leadership in muscle biology affords us multiple opportunities to advance our drug candidates as our clinical trials generate clinical evidence to support the promise of potential new therapies.”
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
AMG 594 (cardiac troponin activator)
CK-3773274 (CK-274, cardiac myosin inhibitor)
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
Pre-Clinical Development and Ongoing Research
Revenues for the three and six months ended June 30, 2019 were $7.1 million and $15.6 million, respectively, compared to $6.2 million and $11.5 million for the corresponding periods in 2018. The increase in revenues for the three and six month ended June 30, 2019 was due primarily to reimbursements for METEORIC-HF offset by no license revenue in 2019. License revenues in the second quarter and first half of 2018 were related to the Phase 2 study of reldesemtiv in spinal muscular atrophy completed in 2018.
Research and development expenses for the three and six months ended June 30, 2019 increased to $24.0 million and $47.6 million, respectively compared to $21.6 million and $43.7 million for the same periods in 2018, respectively due to increased spending related to METEORIC-HF and the development of CK-274, offset in part by reduced spending for reldesemtiv as well as for tirasemtiv, following suspension of development of tirasemtiv in late 2017.
General and administrative expenses for the three and six months ended June 30, 2019 increased to $9.8 million and $19.3 million from $8.0 million and $17.3 million in 2018 due primarily to an increase in outside legal counsel and personnel related costs.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s second quarter 2019 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 1778276.
An archived replay of the webcast will be available via Cytokinetics’ website until August 15, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 1778276 from August 8, 2019 at 7:30 PM Eastern Time until August 15, 2019.
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to develop reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for diseases of neuromuscular dysfunction, including SMA and ALS. Astellas holds an exclusive worldwide license to develop and commercialize reldesemtiv. Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.
For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of clinical trials; the significance and utility of pre-clinical study and clinical trial results; planned interactions with regulatory authorities and the outcomes of such interactions; the expected timing of events and milestones, including the receipt of milestone payments; and the properties and potential benefits of Cytokinetics’ drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Amgen’s and Astellas’ decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil and reldesemtiv, respectively; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Vice President, Corporate Communications, Investor Relations
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
|Three Months Ended||Six Months Ended|
|June 30, 2019||June 30, 2018||June 30, 2019||June 30, 2018|
|Research and development revenues||$||7,137||$||4,680||$||15,601||$||8,265|
|Research and development||24,017||21,582||47,562||43,717|
|General and administrative||9,836||8,046||19,273||17,310|
|Total operating expenses||33,853||29,628||66,835||61,027|
|Non-cash interest expense on liability related to the sale of future royalties||(5,064||)||(4,338||)||(9,883||)||(8,467||)|
|Interest and other income||1,044||1,126||2,185||1,968|
|Net loss per share — basic and diluted||$||(0.56||)||$||(0.51||)||$||(1.09||)||$||(1.07||)|
|Weighted-average shares in net loss per share — basic and diluted||57,648||54,293||56,242||54,178|
Condensed Consolidated Balance Sheets
|June 30, 2019||December 31, 2018(1)|
|Cash and short term investments||$||172,868||$||198,731|
|Other current assets||12,083||8,943|
|Total current assets||184,951||207,674|
|Property and equipment, net||2,945||3,204|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$||17,022||$||19,521|
|Current portion of long-term debt||-||2,607|
|Short-term lease liability||4,538||—|
|Other current liabilities||399||66|
|Total current liabilities||21,959||22,194|
|Long-term debt, net||44,473||39,806|
|Liability related to the sale of future royalties, net||132,388||122,473|
|Long-term lease liability||4,294||—|
|Other long-term liabilities||—||771|
|Additional paid-in capital||799,088||768,703|
|Accumulated other comprehensive income||761||500|
|Total stockholders’ equity||(4,896||)||25,934|
|Total liabilities and stockholders’ equity||$||198,218||$||211,178|
(1) Derived from the audited financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018.